Model Number 209999 |
Device Problems
Positioning Failure (1158); Incorrect Measurement (1383)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/31/2019 |
Event Type
malfunction
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Manufacturer Narrative
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As part of the normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.
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Event Description
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Surgeon states the acetabular cup is more vertical than he would like.Please investigate the case steps for registration, etc.Under complaints file named: (b)(4).Case type: tha.Update: "estimated discrepancy is 60 inclination, 25 version.".
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Manufacturer Narrative
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Reported event.An event regarding inaccurate resection involving a mako tha software was reported.The event was not confirmed.Method & results.Review of the log/session files has not been completed within 90days of the complaint being opened.The complaint will be closed with an associated risk assessment.Additional failures will be assessed once the log/session file review has been completed.Clinician review: no medical records were received for review with a clinical consultant.Product history review: a review of device history records shows that (b)(6) was inspected on 09/08/2017 and the quality inspection procedures were completed with no reported discrepancies.Complaint history review: a review of complaints in trackwise related to p/n 209999, robot number: (b)(6) shows 0 similar complaints for tha software - inaccurate resection.Conclusions: the exact cause of the event could not be determined because insufficient information was made available for evaluation.Review of the log/session files has not been completed within 90 days of the complaint being opened.A review of the case session/log data is needed to complete a full investigation for determining root cause.In addition to a review of the log/session, a field service engineer conducts scheduled maintenance on the robot to ensure the robot is system ready.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.Device not returned.
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Event Description
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Surgeon states the acetabular cup is more vertical than he would like.Please investigate the case steps for registration, etc.Under complaints file named: (b)(6) hospital (b)(6) 2019.Post-op xr attached as well.Case type: tha.Update: "estimated discrepancy is 60 inclination, 25 version.".
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Search Alerts/Recalls
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